| CTRI Number |
CTRI/2019/10/021658 [Registered on: 15/10/2019] Trial Registered Prospectively |
| Last Modified On: |
14/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to know role of usg and different approach in central vein cannulation |
|
Scientific Title of Study
|
A comparative Study to evaluate long axis, short axis and medial oblique axis approach for ultrasound guided internal jugular vein cannulation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR jatin lal |
| Designation |
Professor |
| Affiliation |
PGIMS, ROHTAK |
| Address |
Department of anesthesiology and critical care pgims UHS Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR jatin lal |
| Designation |
Professor |
| Affiliation |
PGIMS, ROHTAK |
| Address |
Department of anesthesiology and critical care pgims UHS Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meenakshi verma |
| Designation |
Pg resident 2 |
| Affiliation |
PGIMS, ROHTAK |
| Address |
Department of anesthesiology and critical care pgims UHS Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8920132156 |
| Fax |
|
| Email |
vermameenakshi331@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology and critical care pgims rohtak |
|
|
Primary Sponsor
|
| Name |
Department of anesthesiology and critical care |
| Address |
Pt. B.D. Sharma medical college and hospital rohtak |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr jatin lal |
Pgims rohtak |
Department of anesthesiology and critical care pgims rohtak
Rohtak
HARYANA |
9728265511
dr.jatinlal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt. B. D. Sharma PGIMS/UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ijv cannulation using usg with three different axis |
Usg guided ijv cannulation using short axis, long axis and medial oblique axis approach |
| Comparator Agent |
Usg guided ijv cannulation using short, long and medial oblique axis approach |
Usg guided ijv cannulation using three different axis short, long and medial oblique axis approach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring ijv cannulation 18 years above of either sex scheduled for elective surgery or admitted in icu |
|
| ExclusionCriteria |
| Details |
Signs of infection, previous surgical intervention at same site, thrombosis in ijv, history of past ijv cannulation during 72 hrs, |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First pass success rate in short axis, long axis and medial oblique axis approach using usg guided ijv cannulation |
Once- at the time of cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications during usg guided ijv cannulation with three different axis |
Once-24 hrs after the cannulation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="24" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A study to compare first pass success, venous access time, guidewire time, catheterization time, overall success rate and complications using usg guided ijv cannulation for three different axis short, long and medial oblique axis approach in elective surgery and icu patients above 18yrs of age |